Quality Assurance Auditor

Overview:

As the QA Auditor, you will perform project and non-project quality assurance duties at PharPoint Research. Responsible for carrying out quality initiatives at the company, including but not limited to SOPs and training, computer systems validation, and Quality Management System.

What you will do:

• Assist with maintaining the Quality Management System (QMS) consistent with current Good Clinical Practices (GCP), Good Documentation Practices (GDP) and other applicable regulatory and ethical requirements.
• Generate and review SOPs, guidance's, forms and templates.
• Conduct vendor audits of current and potential vendors.
• Conduct periodic internal audits.
• Conduct essential document audits (e.g., TMF, CSR, etc.).
• Assist in the preparation, conduct and follow up of external audits of PharPoint.
• Support company regulatory GCP inspections, as needed.
• Contribute to the review, management and follow up of quality events, CAPAs and deviations.
• Assist with tracking of GCP quality system metrics such as quality events, CAPAs, deviations and audit findings.
• Participate in computer system validation and change control activities.
• Interface with clients, internal and external stakeholders, and vendors, as needed.
• Adhere to all aspects of PharPoint’s Quality Management System.
• Comply with PharPoint’s data integrity and business ethics requirements.
• Perform all other related duties as assigned

Qualifications:

• Education: Bachelor’s degree (B.A./B.S.) or equivalent in a scientific, computer, or related discipline. Advanced degree or technical certification(s) preferred.
• Experience: Minimum 1-2 years’ experience in quality assurance, quality control, and/or validation.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Computer system validation experience highly preferred
• Other: Knowledge and understanding of ICH Guidelines for Good Clinical Practice, Title 21 of the Code of Federal Regulations, and good industry practices involving Quality. Knowledge expert in industry regulations and standards. Demonstrated professional presentation capabilities. Ability to read, write, speak and understand English required.